NDC Code(s) : 13668-107-30, 13668-107-90
Packager : Torrent Pharmaceuticals Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rabeprazole sodiumRabeprazole sodium TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13668-107
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RABEPRAZOLE SODIUM(UNII: 3L36P16U4R)
(RABEPRAZOLE - UNII:32828355LL) 		RABEPRAZOLE SODIUM20 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
DIETHYL PHTHALATE(UNII: UF064M00AF)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)(UNII: G4U024CQK6)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
POVIDONE(UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code 107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13668-107-3030 in 1 BOTTLE Type 0: Not a Combination Product11/08/2013
2NDC:13668-107-9090 in 1 BOTTLE Type 0: Not a Combination Product11/08/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202376 11/08/2013

LABELER - Torrent Pharmaceuticals Limited(916488547)

REGISTRANT - Torrent Pharma, Inc.(790033935)

Establishment
Name Address ID/FEI Business Operations
Torrent Pharmaceuticals Limited 916488547 manufacture(13668-107)

PRINCIPAL DISPLAY PANEL

Rabeprazole Sodium Delayed-Release Tablets 20 mg

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